Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with somatoform disorders

Background: The EQ-5D is a generic questionnaire providing a preference-based index score applicable to cost-utility analysis. This is the first study to validate the EQ-5D in patients with somatoform disorders. Methods: Data of the EQ-5D descriptive system, the British and the German EQ-5D index and the EQ Visual Analogue Scale, the Patient Health Questionnaire 15, the Patient Health Questionnaire 9, the Whiteley Index 7 and the Short Form 36 were collected from 294 patients at baseline, 244 at 6 months and 256 at 12 months after baseline. The discriminative ability of the EQ-5D was evaluated by comparison with a general population sample and by the ability to distinguish between different symptom severities. Convergent validity was analysed by assessing associations between the EQ-5D and the other instruments. Responsiveness was evaluated by analysing the effects on scores between two measurements in groups of patients reporting worse, same or better health. The Bonferroni correction was employed. Results: For all items of the EQ-5D except ‘self-care’, patients with somatoform disorders reported more problems than the general population. The EQ-5D showed discriminative ability in patients with different symptom severities. For nearly all reference instruments there were significant differences in mean scores between respondents with and without problems in the various EQ-5D items and strong correlations with the EQ Visual Analogue Scale and the EQ-5D index scores. Evidence for the responsiveness of the EQ-5D could only be found for patients with better health; effects were medium at the utmost. Conclusions: The EQ-5D showed a considerable validity and a limited responsiveness in patients with somatoform disorders. Trial registration: Current Controlled Trials ISRCTN5528079

Economics of medically unexplained symptoms: a systematic review of the literature

Objective: To review cost-of-illness studies (COI) and economic evaluations (EE) conducted for medically unexplained symptoms and to analyze their methods and results. Methods: We searched the databases PubMed, PsycINFO and National Health Service Economic Evaluations Database of the University of York. Cost data were inflated to 2006 using country-specific gross domestic product inflators and converted to 2006 USD purchasing power parities. Results: We identified 5 COI and 8 EE, of which 6 were cost-minimization analyses and 2 were cost-effectiveness analyses. All studies used patient level data collected between 1980 and 2004 and were predominantly conducted in the USA (n = 10). COI found annual excess health care costs of somatizing patients between 432 and 5,353 USD in 2006 values. Indirect costs were estimated by only one EE and added up to about 18,000 USD per year. In EE, educational interventions for physicians as well as cognitive-behavioral therapy approaches for patients were evaluated. For both types of interventions, effectiveness was either shown within EE or by previous studies

Management of patients with persistent medically unexplained symptoms: a descriptive study

Background: In 2013 the Dutch guideline for management of medically unexplained symptoms (MUS) was published. The aim of this study is to assess medical care for patients with persistent MUS as recorded in their electronic medical records, to investigate if this is in line with the national guideline for persistent MUS and whether there are changes in care over time. Methods: We conducted an observational study of adult primary care patients with MUS. Routinely recorded health care data were extracted from electronic medical records of patients participating in an ongoing randomised controlled trial in 30 general practices in the Netherlands. Data on general practitioners’ (GPs’) management strategies during MUS consultations were collected in a 5-year period for each patient prior. Management strategies were categorised according to the options offered in the Dutch guideline. Changes in management over time were analysed. Results: Data were collected from 1035 MUS consultations (77 patients). Beside history-taking, the most frequently used diagnostic strategies were physical examination (24.5%) and additional investigations by the GP (11.1%). Frequently used therapeutic strategies were prescribing medication (24.6%) and providing explanations (11.2%). As MUS symptoms persisted, GPs adjusted medication, discussed progress and scheduled follow-up appointments more frequently. The least frequently used strategies were exploration of all complaint dimensions (i.e. somatic, cognitive, emotional, behavioural and social) (3.5%) and referral to a psychologist (0.5%) or psychiatrist (0.1%). Conclusions: Management of Dutch GPs is partly in line with the Dutch guideline. Medication was possibly prescribed more frequently than recommended, whereas exploration of all complaint dimensions, shared problem definition and referral to mental health care were used less

Predictors of persistent medically unexplained physical symptoms: findings from a general population study

Objective: To explore the course persistency of Medically Unexplained Symptoms (MUS) and its prognostics factors in the general adult population. Knowledge of prognostic factors of MUS may indicate possible avenues for intervention development. Methods: Data were derived from the Netherlands Mental Health Survey and Incidence Study-2 (NEMESIS-2), a nationally representative face-to-face cohort study among the Dutch general population aged 18-64 years. We selected subjects with MUS at baseline and who participated at follow-up (N=324) and reassessed those subjects for having MUS at three year follow-up. Logistic regression analyses were used to determine risk factors for persistency of MUS. Results: 36.4% of the subjects had persistent MUS at follow-up. In logistic regression analyses adjusted for sex and age, persistency of MUS was predicted by the number of comorbid chronic medical disorder(s), lower education, female sex, not having a paid job, parental psychopathology as well as lower functioning. In the logistic regression analysis in which all significant variables adjusted for sex and age were entered simultaneously, three variables predicted persistent MUS: parental psychopathology, the number of comorbid chronic medical disorder(s) and physical functioning, with odds ratios of 2.01 (1.20-3.38), 1.19 (1.01-1.40) and 0.99 (0.97-1.00), respectively. Conclusion: In the adult general population, MUS were persistent in over one third of the subjects with MUS at baseline. Persistency was uniquely significantly predicted by parental psychopathology, number of comorbid chronic medical disorders and physical functioning. These findings warrant further research into early intervention and treatment options for persons with an increased risk of persistent MUS

Economic burden associated with alcohol dependence in a German primary care sample : a bottom-up study

BACKGROUND: A considerable economic burden has been repeatedly associated with alcohol dependence (AD) - mostly calculated using aggregate data and alcohol-attributable fractions (top-down approach). However, this approach is limited by a number of assumptions, which are hard to test. Thus, cost estimates should ideally be validated with studies using individual data to estimate the same costs (bottom-up approach). However, bottom-up studies on the economic burden associated with AD are lacking. Our study aimed to fill this gap using the bottom-up approach to examine costs for AD, and also stratified the results by the following subgroups: sex, age, diagnostic approach and severity of AD, as relevant variations could be expected by these factors. METHODS: SAMPLE: 1356 primary health care patients, representative for two German regions. AD was diagnosed by a standardized instrument and treating physicians. Individual costs were calculated by combining resource use and productivity data representing a period of six months prior to the time of interview, with unit costs derived from the literature or official statistics. The economic burden associated with AD was determined via excess costs by comparing utilization of various health care resources and impaired productivity between people with and without AD, controlling for relevant confounders. Additional analyses for several AD characteristics were performed. RESULTS: Mean costs among alcohol dependent patients were 50 % higher compared to the remaining patients, resulting in 1836 € excess costs per alcohol dependent patient in 6 months. More than half of these excess costs incurred through increased productivity loss among alcohol dependent patients. Treatment for alcohol problems represents only 6 % of these costs. The economic burden associated with AD incurred mainly among males and among 30 to 49 year old patients. Both diagnostic approaches were significantly related to the economic burden, while costs increased with alcohol use disorder severity but not with other AD severity indicators. CONCLUSIONS: Our study confirms previous studies using top-down approaches to estimate the economic burden associated with AD. Further, we highlight the need for efforts aimed at preventing adverse outcomes for health and occupational situation associated with alcohol dependence based on factors associated with particularly high economic burden

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

Background: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. Methods: In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. Discussion: We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Trial registration: Dutch Trial Registry, identifier: NTR4686, Registered on 14 July 2014. © 2017 The Author(s)

The Excess Costs of Depression and the Influence of Sociodemographic and Socioeconomic Factors: Results from the German Health Interview and Examination Survey for Adults (DEGS)

Introduction The aim of this study was to estimate excess costs of depression in Germany and to examine the influence of sociodemographic and socioeconomic determinants. Methods Annual excess costs of depression per patient were estimated for the year 2019 by comparing survey data of individuals with and without self-reported medically diagnosed depression, representative for the German population aged 18–79 years. Differences between individuals with depression (n = 223) and without depression (n = 4540) were adjusted using entropy balancing. Excess costs were estimated using generalized linear model regression with a gamma distribution and log-link function. We estimated direct (inpatient, outpatient, medication) and indirect (sick leave, early retirement) excess costs. Subgroup analyses by social determinants were conducted for sex, age, socioeconomic status, first-generation or second-generation migrants, partnership, and social support. Results Total annual excess costs of depression amounted to €5047 (95% confidence interval [CI] 3214–6880) per patient. Indirect excess costs amounted to €2835 (1566–4103) and were higher than direct excess costs (€2212 [1083–3341]). Outpatient (€498), inpatient (€1345), early retirement (€1686), and sick leave (€1149) excess costs were statistically significant, while medication (€370) excess costs were not. Regarding social determinants, total excess costs were highest in the younger age groups (€7955 for 18–29-year-olds, €9560 for 30–44-year-olds), whereas total excess costs were lowest for the oldest age group (€2168 for 65+) and first-generation or second-generation migrants (€1820). Conclusions Depression was associated with high excess costs that varied by social determinants. Considerable differences between the socioeconomic and sociodemographic subgroups need further clarification as they point to specific treatment barriers as well as varying treatment needs.Peer Reviewe

The responsiveness of the EQ-5D and time trade-off scores in schizophrenia, affective disorders, and alcohol addiction

OBJECTIVE: To compare the responsiveness of the EQ-5D index (German and British tariff), the EQ-5D visual analogue scale (EQ VAS), and time trade-off (TTO) scores in schizophrenia, affective disorders, and alcohol addiction. METHODS: We used a sample of 502 patients and examined the measures at baseline and after 14 months. We used the generic “WHO Quality of Life BREF” (WHOQOL) and the disorder-specific “Global Severity Index” (GSI) as anchors for a relevant improvement in a patient’s health status. In a complete case analysis, we assessed the responsiveness, which is the ability to detect a change given a relevant change on the anchor. We computed the effect sizes (ESs) and standardised response means (SRMs). RESULTS: In patients with schizophrenia, the ESs and SRMs were large (ES/SRM > 0.8) for the British EQ-5D index (ES(GSI): 0.93; SRM(GSI): 0.89; SRM(WHOQOL): 0.82). In patients with affective disorders, we found large ESs and SRMs for the EQ VAS (ES(GSI): 1.79; ES(WHOQOL): 0.90; SRM(GSI): 1.52; SRM(WHOQOL): 0.93) and a large ES for the British EQ-5D index (ES(GSI): 0.88). In patients with alcohol addiction, the ESs and SRMs were large for the EQ VAS (ES(GSI): 1.40; ES(WHOQOL): 0.94; SRM(GSI): 1.04; SRM(WHOQOL): 0.83). The ESs and SRMs of the German EQ-5D index were consistently lower than those of the British EQ-5D index. Regarding TTO score, ESs and SRMs were generally less than 0.5. CONCLUSIONS: No preference-based instrument was consistently more responsive than others across all mental disorders. While the EQ VAS was the most responsive instrument in patients with affective disorders or alcohol addiction, the British EQ-5D index was reasonably responsive in patients with schizophrenia. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12955-015-0315-4) contains supplementary material, which is available to authorized users

Placement matching of alcohol-dependent patients based on a standardized intake assessment: rationale and design of a randomized controlled trial

BACKGROUND: Despite considerable research on substance-abuse placement matching, evidence is still inconclusive. The aims of this exploratory trial are to evaluate (a) the effects of following matching guidelines on health-care costs and heavy drinking, and (b) factors affecting the implementation of matching guidelines in the treatment of alcohol-dependent patients. METHODS: A total of 286 alcohol-dependent patients entering one of four participating detoxification units and having no arrangements for further treatment will be recruited. During the first week of treatment, all patients will be administered Measurements in the Addictions for Triage and Evaluation (MATE), European Quality of Life-Five Dimensions health status questionnaire (EQ-5D), and the Client Socio-Demographic and Service Receipt Inventory—European Version (CSSRI-EU). Patients who are randomly allocated to the intervention group will receive feedback regarding their assessment results, including clear recommendations for subsequent treatment. Patients of the control group will receive treatment as usual and, if requested, global feedback regarding their assessment results, but no recommendations for subsequent treatment. At discharge, treatment outcome and referral decisions will be recorded. Six months after discharge, patients will be administered MATE-Outcome, EQ-5D, and CSSRI-EU during a telephone interview. DISCUSSION: This trial will provide evidence on the effects and costs of using placement-matching guidelines based on a standardized assessment with structured feedback in the treatment of alcohol-dependent patients. A process evaluation will be conducted to facilitate better understanding of the relationship between the use of guidelines, outcomes, and potential mediating variables. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005035. Registered 03 June 2013

The course of pain intensity in patients undergoing herniated disc surgery: a 5-year longitudinal observational study

Objectives: The aims of this study are to answer the following questions (1) How does the pain intensity of lumbar and cervical disc surgery patients change within a postoperative time frame of 5 years? (2) Which sociodemographic, medical, work-related, and psychological factors are associated with postoperative pain in lumbar and cervical disc surgery patients? Methods: The baseline survey (T0; n = 534) was conducted 3.6 days (SD 2.48) post-surgery in the form of face-to-face interviews. The follow-up interviews were conducted 3 months (T1; n = 486 patients), 9 months (T2; n = 457), 15 months (T3; n = 438), and 5 years (T4; n = 404) post-surgery. Pain intensity was measured on a numeric rating-scale (NRS 0–100). Estimated changes to and influences on postoperative pain by random effects were accounted by regression models. Results: Average pain decreased continuously over time in patients with lumbar herniated disc (Wald Chi² = 25.97, p<0.001). In patients with cervical herniated disc a reduction of pain was observed, albeit not significant (Chi² = 7.02, p = 0.135). Two predictors were associated with postoperative pain in lumbar and cervical disc surgery patients: the subjective prognosis of gainful employment (p<0.001) and depression (p<0.001). Conclusion: In the majority of disc surgery patients, a long-term reduction of pain was observed. Cervical surgery patients seemed to benefit less from surgery than the lumbar surgery patients. A negative subjective prognosis of gainful employment and stronger depressive symptoms were associated with postoperative pain. The findings may promote multimodal rehabilitation concepts including psychological and work-related support